All cosmetics placed in the Chinese market shall comply with the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics. This is the English version of the provisions released by NMPA (National Medical Products Administration) which is responsible for the supervision and administration of cosmetics nationwide.
Chapter I General Provisions
Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics for the purpose of regulating the manufacturing and marketing of cosmetics, strengthening supervision and administration of cosmetics, and ensuring the quality and safety of cosmetics.
Article 2 These Provisions shall apply to the manufacturing and marketing of cosmetics, supervision, and administration in this respect within the territory of the People's Republic of China.
Article 3 The National Medical Products Administration (NMPA) shall be responsible for the supervision and administration of cosmetics nationwide.
The department in charge of drug supervision and administration of local people's governments at or above the county level shall be responsible for the supervision and administration of cosmetics within their administrative areas.
Article 4 The registrant and the filing entity of cosmetics shall establish a quality management system for cosmetics manufacturing according to law, perform obligations related to the product including adverse reaction monitoring, risk control, recall, etc, and shall be responsible for their quality, safety and efficacy claims of cosmetics. Manufacturers and marketers of cosmetics shall comply with laws, regulations, provisions, mandatory national standards, and technical specifications in engaging in manufacturing and marketing activities and conduct vigorous management, maintain integrity, and practice self-discipline, thus ensuring the quality and safety of cosmetics.
Article 5 The state exercises licensing management for the manufacturing of cosmetics. To engage in the manufacturing of cosmetics, the Cosmetics Manufacturing License shall be obtained in accordance with the law.
Article 6 Manufacturers and marketers of cosmetics shall establish, in accordance with the law, a documentation system for the check and test of purchases, product sales records, and other systems, to ensure the traceability of the products.
Manufacturers and marketers of cosmetics are encouraged to adopt information technology to collect and store information on manufacturing and marketing and establish a traceability system for the quality and safety of cosmetics.
Article 7 The NMPA shall enhance informatization construction, to provide convenient services for the public in inquiring information on cosmetics.
The department in charge of drug supervision and administration shall, in accordance with the law, promptly publish regulatory information on cosmetics manufacturing licenses, supervision, inspection, administrative penalty, etc.
Article 8 The department in charge of drug supervision and administration shall give full play to the role of the associations of the cosmetics industry, the associations of consumers and other consumer organizations, news media, etc., promote the construction of an industry integrity system, and advance social co-governance for cosmetics safety.
Chapter II Manufacturing License
Article 9 Applicants for the cosmetics manufacturing license shall meet the following requirements:
(1) being an enterprise established according to law;
(2) having manufacturing premises that are appropriate to the varieties, quantity, and manufacturing licensed items, etc. of the cosmetics produced, and being kept prescribed distance from toxic and hazardous premises and other sources of pollution;
(3) having the manufacturing facilities and equipment that are appropriate to the varieties, quantity, and manufacturing licensed items, etc. of the cosmetics produced, and having a reasonable layout thereof, and the air purification, water treatment facilities, and equipment, etc. that meet the specified requirements;
(4) having technicians who are suited to the varieties, quantity, and manufacturing licensed items, etc. of the cosmetics manufactured;
(5) having the staff members and equipment that are appropriate to the varieties and quantity of the cosmetics produced and that can perform an inspection of the cosmetics produced;
(6) having a management system for guaranteeing the quality and safety of the cosmetics.
Article 10 The applicants for cosmetics manufacturing license shall submit an application to the drug regulatory department of the province, autonomous region, or municipality directly under the central government, where it is located, submit the documents proving that they meet the requirements as specified in Article 9 of these Provisions, and shall be accountable for the authenticity of the documents.
Article 11 Regarding the application submitted by applicants for a cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall handle respectively according to the following circumstances:
(1) If the application items do not require licensing in accordance with the law, the relevant department shall make a decision of non-acceptance, and issue a notification of non-acceptance;
(2) If the application items are not within the scope of authority of the drug regulatory department in accordance with the law, the relevant department shall make a decision of non-acceptance, issue a notification of non-acceptance, and inform the applicant to resubmit the application to the applicable administrative authority；
(3) If the application documents contain errors that can be corrected on-site, the applicant shall be allowed to make corrections on-site, affix a signature or seal to the correction, and indicate the date of correction thereon;
(4) If the application documents are incomplete or do not conform to statutory form, the applicant shall be notified of all contents that ought to be supplemented and corrected on-site or within 5 working days one-off. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application documents;
(5) The application for a cosmetics manufacturing license shall be accepted if the documents are complete and conform to the statutory form, or if the applicant has submitted all the supplementary and corrected documents as required.
For acceptance or non-acceptance of the application for a cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall issue an acceptance or non-acceptance notice. If non-acceptance is determined, the reason for non-acceptance shall be given, and the applicants shall be informed of being entitled to apply for administrative reconsideration or file administrative litigation according to law.
Article 12 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall review the application documents submitted by the applicant, conduct an on-site inspection of the manufacturing premises of the applicant, and make a decision within 30 working days beginning from the date of acceptance of the application for a cosmetics manufacturing license.
Article 13 The drug regulatory department of the province, autonomous region or municipality directly under the central government shall, according to the review of the application documents and on-site inspection, grant approval for application if the specified requirements are met, and issue cosmetic manufacturing license to the applicant within 5 working days upon making the decision; if the specified requirements are not met, it shall not grant approval and shall give the reasons in writing in a timely manner, and in the meantime inform the applicant of being entitled to apply for administrative reconsideration or file administrative litigation according to law.
Issuing date of the Cosmetics Manufacturing License is the date on which the decision on granting is made, and the valid term is 5 years.
Article 14 The Cosmetics Manufacturing License has the original copy and the duplicate. The original copy and the duplicate have equal legal effects.
The NMPA shall be responsible for making a template for the Cosmetics Manufacturing License. The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for printing, issuing, and other management work of the cosmetics manufacturing license.
The electronic Cosmetics Manufacturing License and the printed Cosmetics Manufacturing License made by the drug regulatory department have equal legal effects.
Article 15 The Cosmetics Manufacturing License shall be indicated with the license number, the manufacturer’s name, domicile, manufacturing address, unified social credit identifier, legal representative or responsible person, the manufacturing licensed items, expiry date, issuing authority and date of issuance, etc.
The duplicate of the Cosmetics Manufacturing License shall also indicate the change of the cosmetics manufacturing licensing.
Article 16 The manufacturing licensed items for cosmetics shall be classified into the general liquid unit, cream emulsion unit, powder unit, aerosol and organic solvent unit, wax-based unit, toothpaste unit, soap-based unit, and other units according to the manufacturing process, status and use of finished products, etc. of the cosmetics. The NMPA may adjust the unit classification of the manufacturing licensed items in accordance with practical needs for supervision and administration of the quality and safety of cosmetics.
Those who have the manufacturing conditions of children's skincare and eye care cosmetics shall be specially indicated in the manufacturing licensed items.
Article 17 If the licensing conditions of applicants or the items specified in the license need to be changed within the validity period of the Cosmetics Manufacturing License, the applicant shall apply to the drug regulatory department that issued that former license for change.
Article 18 In case of changes in the manufacturing licensed items, or changes in the manufacturing facilities and equipment that may affect the product quality and safety, or workshops are newly built, rebuilt, or expanded on the original cosmetic manufacturing premises, cosmetics manufacturers shall apply to the drug regulatory department that issued the former license for change before manufacturing, and submit documents related to the change as specified in Article 10 of these Provisions. The drug regulatory department that issued a former license shall conduct the review, and make a decision on whether to grant approval for change or not within 30 working days upon acceptance of the application for change and keep a record of duplicates of the Cosmetics Manufacturing License. If it needs to make an on-site inspection, it shall be handled as specified in Article 12 of these Provisions.
Where a comprehensive on-site inspection is required due to changes in manufacturing licensed items, etc., if the manufacturer conforms to requirements upon on-site inspection by the drug regulatory department of the province, autonomous region, or municipality directly under the central government, a new Cosmetics Manufacturing License shall be issued with the license number unchanged, and the validity period thereof will be recalculated from the date of issuance.
Where the same cosmetics manufacturer applies for adding the manufacturing address of cosmetics in the same province, autonomous region, or municipality directly under the central government, it may handle the procedures for change in accordance with provisions in these Provisions.
Article 19 Where the name, domicile, legal representative or responsible person, etc., of manufacturer change, the cosmetics manufacturer shall apply to the drug regulatory department issued that former license for change within 30 working days from the date of the change, and submit documents related to the change. The drug regulatory department that issued the former license shall handle the procedures for change within 3 working days upon acceptance of the application.
Where there is a change in the person in charge of quality and safety and the registered contact information, etc., the cosmetics manufacturer shall report to the drug regulatory department that issued the former license within 10 working days of the change.
Article 20 If the renewal of the Cosmetics Manufacturing License is needed at the expiration of the validity, the applicant shall submit an application for renewal of the license to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where it is located within 30-90 working days before the expiry date, and commit that it conforms to the conditions for the cosmetics manufacturing license as specified in these Provisions. The applicant shall be responsible for the authenticity and legality of the documents submitted and the commitment made.
Where the application for the renewal of the license is not submitted before the prescribed time limit, the application for the renewal thereof shall no longer be accepted.
Article 21 The drug regulatory department of the province, autonomous region or municipality directly under the central government shall conduct a formal review of the application documents within 5 working days upon receiving the application for renewal of license, accept the application if it meets the requirements, and issue a new Cosmetics Manufacturing License to the applicant within 10 working days upon acceptance. The valid term of the license shall be recalculated from the day following the expiration date of the former license.
Article 22 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall supervise the application documents and commitments of the cosmetics manufacturer that obtained the renewal of license, and in case of finding out non-conformance to the conditions for cosmetics manufacturing license as specified in Article 9 of these Provisions, it shall withdraw the Cosmetics Manufacturing License according to law.
Article 23 In one of the following circumstances with the manufacturer of cosmetics, the drug regulatory department that issued the former license shall cancel the Cosmetics Manufacturing License according to law, and publish it on the government website:
(1) The enterprise takes the initiative to apply for cancellation;
(2) The enterprise's eligibility as an entity is terminated according to law;
(3) Cosmetics Manufacturing License is not renewed upon expiration;
(4) Cosmetics Manufacturing License is withdrawn or canceled according to law, or the license for the production of cosmetics is revoked according to law;
(5) Other circumstances where the cosmetics manufacturing license shall be canceled as prescribed by laws and regulations.
When the cosmetics manufacturer applies for canceling the cosmetics manufacturing license, if the drug regulatory department that issued the former license finds out that cancellation may affect the investigation of cases, it may suspend handling of the cancellation procedures.
Chapter III Manufacturing of Cosmetics
Article 24 The NMPA shall formulate the Good Manufacturing Practice for Cosmetics, and specify the requirements for the quality management structure and personnel, quality assurance and control, plant facilities and equipment management, materials and products management, manufacturing process management, and product sales management, etc.
The registrant, the filing entity and the contract manufacturer of cosmetics shall, in accordance with requirements of the Good Manufacturing Practice for Cosmetics, organize the manufacturing of cosmetics, establish a quality management system for cosmetics manufacturing and guarantee continuous and effective operation. In the manufacturing workshop and other premises, any other product that has an adverse effect on the quality of the cosmetics shall neither be stored nor produced
Article 25 The registrant, the filing entity, and the contract manufacturer of cosmetics shall establish and implement the management systems to ensure the quality and safety of cosmetics, such as material supplier selection, check and test for raw materials acceptance, manufacturing process, and quality control, equipment maintenance and product test and sample retention, etc.
Article 26 If the registrant or the filing entity of cosmetics entrusts manufacturing of cosmetics, it shall entrust one that has obtained the manufacturing license for the relevant cosmetics and shall supervise the whole manufacturing process of the entrusted enterprise, and be responsible for quality and safety of the cosmetics entrusted with manufacturing. The contract manufacturer shall have the corresponding manufacturing conditions, and organize manufacturing in accordance with the laws, regulations, mandatory national standards, technical specifications, and contractual agreements, be responsible for the manufacturing, and be supervised by the entrusting party.
Article 27 The registrant, the filing entity, and the contract manufacturer of cosmetics shall establish a responsibility system for the quality and safety of cosmetics, and implement subject responsibility for the quality and safety of cosmetics.
The legal representative and principal responsible person of the registrant, the filing entity, and the contract manufacturer shall assume full responsibility for the quality and safety of cosmetics.
Article 28 The person in charge of quality and safety shall, in accordance with the requirements of the responsibility system for the quality and safety of cosmetics, assist the legal representative and principal responsible person of the registrant, the filing entity, and the contract manufacturer of cosmetics to undertake the corresponding responsibilities for product quality and safety management and product release as follows:
(1) Establish and organize the implementation of the quality management system of the enterprise, and implement the responsibility for quality and safety management;
(2) Management for review of the product formula, manufacturing process and material supplier, etc.;
(3) Material release management and product release;
(4) Management of adverse reaction monitoring of cosmetics;
(5) Supervision and administration of manufacturing activities of the contract manufacturer.
The person in charge of quality and safety shall have professional knowledge and legal knowledge related to the quality and safety of cosmetics in aspects of cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health, or law, etc., be familiar with relevant laws, regulations, provisions, mandatory national standards, and technical specifications, and have at least 5 years of experience in manufacturing or quality management of cosmetics.
Article 29 The registrant, the filing entity, and the contract manufacturer of cosmetics shall establish and implement the health management system for employees, and establish health files for the employees. The health files shall be kept for at least 3 years.
Personnel engaged in the manufacturing of cosmetics directly shall receive a health examination every year. A person who suffers from a disease that is harmful to the quality and safety of cosmetics as specified by the competent health department under the State Council shall not directly engage in the manufacturing of cosmetics.
Article 30 The registrant, the filing entity, and the contract manufacturer of cosmetics shall formulate an annual training plan for the employees, carry out training on laws, regulations, provisions, mandatory national standards, technical specifications, and other knowledge related to cosmetics, and establish training files. Operating and testing personnel for manufacturing should have corresponding knowledge and practical operation skills.
Article 31 The cosmetics should be marked only after they pass the release testing.
The registrant and the filing entity of cosmetics shall retain samples of the released cosmetics in accordance with provisions and keep records. The sample retention shall maintain the original sales package and the quantity shall meet the requirements for product quality testing. The sample retention shall be not less than 6 months upon expiration of the shelf life of the products.
For entrusted manufacturing of cosmetics, the contract manufacturer shall also retain samples and keep records in accordance with the preceding paragraph.
Article 32 The registrant, the filing entity, and the contract manufacturer of cosmetics shall establish and implement a documentation system for the check and test of purchases and product sales records of raw materials and packaging materials contacted with cosmetics. The records of purchase check and test and product sales shall be authentic, complete, and fully traceable, the preservation period shall be not less than one year after the expiration of the shelf life of the products; if the shelf life of a product is less than one year, the preservation period for the records shall be not less than two years.
For entrusted manufacturing of cosmetics, the documentation for the check and test of purchases of raw materials and packaging materials in contact with cosmetics could be kept by the contract manufacturer.
Article 33 The registrant, the filing entity, and the contract manufacturer of cosmetics shall carry out an annual internal audit with respect to the implementation of the Good Manufacturing Practice for Cosmetics. The internal audit report shall include the problems discovered, product quality and safety evaluation, rectification measures, etc., and shall be kept for not less than 2 years.
Where changes occur in the manufacturing conditions are discovered upon internal audit, so that the conditions no longer meet the requirements of Good Manufacturing Practice for cosmetics, the registrant, the filing entity, and the contract manufacturer of cosmetics shall immediately take measures for rectification; upon discovering that the quality and safety of cosmetics may be affected, they shall immediately stop the manufacturing and report the matter to the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located. Manufacturing can be resumed only upon the removal of the risk factors affecting quality and safety. The drug regulatory department of the province, autonomous region, or municipality directly under the central government may organize on-site inspection based on actual conditions.
Article 34 If the registrant, the filing entity, and the contract manufacturer of cosmetics have suspended manufacturing for more than 1 year consecutively, it shall make a comprehensive internal audit before the manufacturing is resumed, and can resume the manufacturing only after confirming that the requirements are met. The internal audit and rectification conditions shall be reported to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where it is located within 10 working days from the date of resumption of manufacturing.
Article 35 A label shall be attached to the minimum sales unit of cosmetics in Chinese. The label contents shall be consistent with the sample manuscript of the product label in the registration or filing documents of the cosmetics.
The name, ingredient, efficacy, and other items of cosmetics indicated on the label shall be authentic and legal, and shall not contain contents that show explicit or implicit medical effects, that are false or misleading, or violate public order and good customs and laws and regulations. If the name of cosmetics uses a trademark, it shall comply with provisions of laws and regulations of the state on trademark management.
Article 36 Cosmetics for children shall comply with requirements for quality and safety of cosmetics for children in laws, regulations, mandatory national standards, technical specifications, and Good Manufacturing Practice for Cosmetics, etc., and shall be indicated on the product label as specified by the NMPA.
Article 37 Where the labeling of cosmetics has the following minor circumstances under which the product quality and safety are not affected and no misleading is caused, it can be deemed as a labeling defect as specified in paragraph 2 of Article 61, of the Regulations on Supervision and Administration of Cosmetics:
(1) the font size of characters, symbols, and numbers are not standardized, or there are multiple characters, missing characters, wrongly written characters, and non-standard Chinese characters;
(2) indication and format of the shelf life and net content are non-standard;
(3) label of the cosmetics is unclear and difficult to identify and read, or some printed characters fall off or are not firmly pasted;
(4) name of the ingredients of the cosmetics is non-standard or the ingredients are not listed in descending order according to the formula content;
(5) other circumstances in violation of regulations on the administration of labels but without impact on the quality and safety of the product and would not mislead the consumers.
Article 38 The registrant, the filing entity, and the contract manufacturer of cosmetics shall take measures to avoid the product character and appearance, etc. from being confused with food, drug, and other products, so as to prevent being eaten or used by mistake.
In the manufacturing and sale of toys and utensils, etc. for juveniles, the precautions shall be indicated according to law, and measures shall be taken to prevent the products from being used as cosmetics for children by mistake.
General cosmetics shall not claim to have the relevant efficacy of special cosmetics.
Chapter IV Marketing of Cosmetics
Article 39 Marketers of cosmetics shall establish and implement the documentation system for the check and test of purchases, to check the market entity registration certificate of the direct supplier, registration certificate of special cosmetics or filing information of general cosmetics, the testing qualification of the product quality and keep relevant vouchers, and truthfully record the name of cosmetics, registration certificate number of special cosmetics or filing number of general cosmetics, shelf life, net content, purchased quantity, supplier’s name, address, contact information, and purchasing date, etc.
Article 40 For marketers of cosmetics implementing uniform delivery, the headquarters of the marketers may establish and implement the documentation systems for the check and test of purchases uniformly, to make uniform checks and tests, documentation, and keep relevant vouchers uniformly in accordance with these Provisions. The headquarters of the marketers shall ensure that the belonging branches can provide relevant records and vouchers regarding the cosmetics under marketing.
Article 41 If the beauty and hair salons and hotels, etc. use cosmetics or provide the consumers with cosmetics during their operation and service process, they shall perform the obligations for marketers of cosmetics prescribed in the Regulations on Supervision and Administration of Cosmetics and these Provisions.
The cosmetics used in the operation of beauty and hair salons and the cosmetics provided to consumers by hotels, etc., shall comply with provisions on the label of the minimum sales unit.
The beauty and hair salons shall display the sales packaging of the cosmetics that they market and provide in prominent places at their service premises, to facilitate the consumers in inquiring about all information on the label of the cosmetics and shall also correctly use or guide the consumers to correctly use the cosmetics as required on label or instructions of the cosmetics.
Article 42 The organizers of centralized trading markets and expos shall establish a management system for ensuring the quality and safety of cosmetics and make effective implementation, undertake the responsibility for managing the participating marketers of cosmetics, urge the participating marketers of cosmetics to perform their obligations according to law, and organize to carry out training on knowledge in quality and safety of cosmetics at least once a year or once during the trade fair period.
The organizer of centralized trading market and expos shall establish files of the participating marketers of cosmetics, review the registration certificate of participated marketers as a market entity, and truthfully record the marketers’ title or name, contact information, domicile, and other information. The file information of the participating marketers of cosmetics shall be verified and updated in a timely manner, to ensure its authenticity, accuracy, and integrity, and shall be not less than 2 years after the marketers suspend the marketing.
The organizer of the trade fair of cosmetics shall, before holding the trade fair, report the basic information such as time, place, etc. of the trade fair to the department of the people's government in charge of drug supervision and administration at the county level.
Article 43 The organizer of the centralized trading market and organizer of the trade fair of cosmetics shall establish the procedures for the inspection of cosmetics, to inspect the marketers' marketing conditions and the cosmetics' quality and safety conditions. If it is found that the participated marketers of cosmetics have behaviors violating the Regulations on Supervision and Administration of Cosmetics and these Provisions, the inspectors shall stop such behaviors in a timely manner, handle them in accordance with regulations on management of centralized trading market or agreement signed with the marketers, and report to the department in charge of drug supervision and administration at the county level where it is located. The organizer of the centralized trading market and organizer of the trade fair of cosmetics are encouraged to establish the system for sample testing and uniform sales voucher format, etc. of cosmetics.
Article 44 Marketers of cosmetic e-commerce platforms and e-commerce marketers via the self-built website and other network services shall disclose labels and other information consistent with that in the registration or filing documents of the cosmetics comprehensively, authentically, and accurately on the platform homepage of their marketing activities.
Article 45 The operators of the cosmetic e-commerce platform shall register the real names of the cosmetic marketers who apply for being stationed in the platform, ask them to submit authentic information on their identity, address and contact information, etc., conduct verification and registration, establish registration files, and carry out verification and updating at least once every 6 months. Operators of an e-commerce platform shall keep the identity information of the cosmetic marketers inside the platforms for not less than 3 years from the date of their withdrawal from the platform.
Article 46 The operator of the cosmetic e-commerce platform shall establish a cosmetics quality management institution or be staffed with full-time and part-time management personnel, establish and effectively implement the system for quality and safety of cosmetics management such as routine inspection of cosmetics, stopping and reporting of illegal acts, handling of complaints and reports, etc., and strengthen the promotion of relevant laws and regulations to marketers of cosmetics in the platform. The operators of an e-commerce platform are encouraged to carry out sample testing.
The operators of the cosmetic e-commerce platform shall assume the responsibility for managing cosmetic marketers within the platform according to law, make daily inspections of the marketing behavior of the cosmetic marketers within the platform, urge the cosmetic marketers within the platform to perform obligations specified in the Regulations on Supervision and Administration of Cosmetics and these Provisions according to law. In case of discovering illegal marketing of cosmetics, the inspectors shall stop timely by necessary means of deleting, shielding and unlinking, etc. in accordance with the laws or with service agreement and trading provisions of the platform, and report to the drug regulatory department of the province, autonomous region or municipality directly under the central government of the place where it is located.
Article 47 If the operators of a cosmetic e-commerce platform receive adverse reaction information or complaint report information of cosmetics, they shall keep a record and submit it to the cosmetic marketers in the platform promptly for handling; in case of involving significant information on quality and safety of the products, they shall report to the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located in a timely manner.
If the department in charge of drug supervision and administration requires the operators of the cosmetic e-commerce platforms to provide relevant information according to law due to the need for supervision and inspection and case investigation, etc., the operator of the cosmetics e-commerce platform shall provide assistance and cooperation.
Article 48 In case of discovering the following serious illegal acts, the operator of the cosmetic e-commerce platform shall immediately suspend the provision of e-commerce platform services for the marketers of cosmetics in the platform:
(1) those who are sentenced to penalties by the People’s Court due to crime related to the quality and safety of cosmetics;
(2) those who are arrested or receive other public security punishment by the public security authorities due to illegal acts related to the quality and safety of cosmetics;
(3) those who receive the punishments such as revoking their license or ordering the suspension of manufacturing and operation, etc. from the drug regulatory department;
(4) Other serious illegal acts.
If the cosmetic marketers within the platform are placed on a file for investigation or are initiated a public prosecution due to being suspected of crime related to the quality and safety of cosmetics, and there is evidence proving that this might cause potential harm to human health, then the operators of cosmetic e-commerce platform could suspend the provision of e-commerce platform services for the cosmetic marketers within the platform in accordance with the laws or with the service agreement and trading provisions of the platform.
If the operators of cosmetic an e-commerce platform know or shall know that the cosmetic marketers in the platform are prohibited from engaging in the manufacturing and marketing of cosmetics according to law, they shall not provide e-commerce platform services to such marketers.
Article 49 Those who provide cosmetics to consumers in the form of a trial for free, gift, or exchange shall fulfill the obligations of cosmetic marketers as specified in the Regulations on Supervision and Administration of Cosmetics and these Provisions.
Chapter V Supervision and Administration
Article 50 The department in charge of drug supervision and administration shall determine in accordance with the principles of risk management, the key varieties, key links, inspection methods, and inspection frequency, etc. of the supervision and inspection, to strengthen supervision and inspection of the manufacturers and marketers of cosmetics.
When necessary, the department in charge of drug supervision and administration can carry out extended inspections of suppliers and manufacturers of the raw materials and packaging materials in contact with cosmetics.
Article 51 The NMPA shall, in accordance with the relevant provisions in laws, regulations, provisions, mandatory national standards and technical specifications, etc., formulate key inspection points of the Good Manufacturing Practice for Cosmetics of the state and other key points of supervision and inspection, and classify the key items and general items of the supervision and inspection as well as the judgment principle for the supervision and inspection. The drug regulatory department of the province, autonomous region, or municipality directly under the central government may refine and supplement key points of supervision and inspection of cosmetics within the administrative areas in combination with the practical situation.
Article 52 The NMPA shall organize and carry out national sample testing of cosmetics. The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall organize and carry out sample testing of cosmetics within the administrative areas. The department in charge of drug supervision of the people's government at the city or county level divided into districts may organize and carry out sample testing of cosmetics within the administrative areas.
For cosmetics that have been reported repeatedly or found to have many problems in routine supervision and inspection, and the cosmetics that may have potential quality and safety problems as discovered from adverse reaction monitoring, safety risk monitoring and assessment, etc., the department in charge of drug supervision and administration may conduct special sample testing.
The department in charge of drug supervision and administration shall publicize sample testing results of the cosmetics according to provisions in a timely manner.
Article 53 If the sample testing results of the cosmetics are non-conforming, the registrant and the filing entity of cosmetics shall, in accordance with the Regulations on Supervision and Administration of Cosmetics, stop manufacturing immediately, recall the cosmetics having entered the market for sale, inform relevant marketers and consumers of stopping marketing and use, and make internal audit in accordance with the Paragraph 2 of Article 33 of these Provisions, and then make rectification.
Article 54 In case of an application for re-testing due to having objections toward the sample testing conclusions, the applicant shall pay the re-testing fees to the re-testing institution in advance. If the re-testing conclusion is consistent with that of the initial testing, the re-testing fees shall be undertaken by the applicant for re-testing. If the re-testing conclusion is inconsistent with that of the initial resting, the re-testing fees shall be undertaken by the drug regulatory department that implements sample testing.
Article 55 Adverse reaction reports of cosmetics follow the principle of reporting if suspected. The NMPA shall establish and improve the system for adverse reaction monitoring of cosmetics and the information system for adverse reaction monitoring of cosmetics.
Article 56 Without consent from the manufacturers and marketers of cosmetics, the department in charge of drug supervision and administration, professional technical institutions, and their staff shall not disclose the business secrets of manufacturers and marketers of cosmetics known in the supervision and inspection process unless otherwise specified by laws or other business secrets involving national security and major social and public interests.
Chapter VI Legal Liability
Article 57 For illegal acts in manufacturing and marketing of cosmetics, if there have been provisions prescribed in the Regulations on Supervision and Administration of Cosmetics and other laws and regulations, such provisions shall prevail.
Article 58 If in violation of Paragraph 1 of Article 17, Article 18, and Paragraph 1 of Article 19 of these Provisions, the cosmetic manufacturer changes its licensing conditions, or needs to change the items stated on the License, but fails to apply for changes as the drug regulatory department issued former license shall order it to make rectification, give warning to it, and impose a fine of not less than RMB 10,000 and not more than RMB 30,000.
If in violation of Paragraph 2 of Article 19 of these Provisions, the person in charge of quality and safety and the reserved contact information are changed, without reporting to the related department as required, the drug regulatory department issued former license shall order the applicant to make rectification; if refusing to make rectification, the department shall give warning, and impose a fine of not more than RMB 5,000.
If the cosmetics manufactured by the cosmetic manufacturer do not belong to the classification units of the licensed items stated on the License for manufacturing of cosmetics, but the manufacturer relocates the premises without licensing or fails to obtain renewal of the license for manufacturing of cosmetics at the expiration of the validity period, it shall be deemed that the manufacturer engages in manufacturing of cosmetics without licensing.
Article 59 If it is found in the supervision and inspection that the registrant, the filing entity, and the contract manufacturer of cosmetics violate the key inspection points of the Good Manufacturing Practice for Cosmetics, and fail to organize manufacturing in accordance with requirements of the Good Manufacturing Practice for Cosmetics, the department in charge of drug supervision and administration shall impose punishment in accordance with the Paragraph 3 of Article 60 of the Regulations on Supervision and Administration of Cosmetics.
If it is found in the supervision and inspection that the registrant, the filing entity, and the contract manufacturer of cosmetics violate provisions on general items in key inspection points of the Good Manufacturing Practice for Cosmetics, but its petty illegal act is rectified in a timely manner, without causing hazardous consequences, it may be exempted from administrative punishment。
Article 60 If in violation of Paragraph 3 of Article 42 of these Provisions, the organizer of a trade fair fails to report the basic information on the trade fair to the department in charge of drug supervision and administration where it is located as required, the department in charge of drug supervision and administration shall order it to make rectification and give warning to it; if refusing to make rectification, the department shall impose a fine of not less than RMB 5,000 and not more than RMB 30,000.
Article 61 Any of the following circumstances shall belong to the serious circumstances stipulated in the Regulations on Supervision and Administration of Cosmetics:
(1) producing raw materials banned from use in the manufacturing of cosmetics, or new raw materials should be registered but not registered to manufacture cosmetics for children, or add substances that may cause potential harm to human health to the cosmetics for children illegally;
(2) providing false information or concealing authentic conditions on purpose;
(3) refusing or evading supervision and inspection;
(4) committing illegal acts of the same nature within 1 year after receiving administrative punishment due to illegal acts related to cosmetics, or committing illegal acts concerning quality and safety of cosmetics after receiving criminal punishment due to violation of laws and regulations on quality and safety of cosmetics;
(5) Other serious circumstances.
When fines are imposed for serious illegal acts, severe and strict punishment shall prevail according to the law.
Article 62 If the manufacturers and marketers of cosmetics violate the laws, regulations, provisions, mandatory national standards, and technical specifications, their illegal acts for the first time with petty hazardous consequences, and they make corrections in a timely manner, they may be exempted from administrative punishment.
Where the party concerned has evidence that is sufficient to prove that it has no subjective fault, there shall be no administrative punishment. If there are separate provisions by laws and administrative regulations, such provisions shall prevail.
Chapter VII Supplementary Provisions
Article 63 For the preparing, filling and canning of cosmetics contents, an entity shall obtain the Cosmetics Manufacturing License according to law. The manufacturing process of the labeling shall be completed by the manufacturer of cosmetics which completes the last manufacturing process of contacting the contents of cosmetics.
Article 64 The technical requirements indicated in the registration or filing documents of cosmetics prescribed in Paragraph 2 of Article 60 of the Regulations on Supervision and Administration of Cosmetics refers to the technical requirements that have a substantial impact on the quality and safety of cosmetics.
Article 65 The number of Cosmetics Manufacturing License is arranged as follows: X妆XXXXXXXX. Where, the first X refers to the abbreviation of the province, autonomous region, or municipality directly under the central government where the licensing department is located, the second to the fifth X refers to the licensing year in 4-digit, and the sixth to the ninth X refer to the licensing serial number in 4-digit.
Article 66 These Provisions shall be effective as of January 1, 2022.
Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.
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